RANITRA: Ranibizumab for Diabetic Traction Retinal Detachment

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01201161

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Retinal Detachment	Drug: Ranibizumab Other: Sham injection	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RANI/PPV Preoperative intravitreal ranibizumab and pars plana vitrectomy	Drug: Ranibizumab Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy Other Names: Lucentis
Placebo Comparator: PPV Sham injection and pars plana vitrectomy	Other: Sham injection Simulation of intravitreal injection one week before pars plana vitrectomy

Arm

Intervention/Treatment

Experimental: RANI/PPV

Preoperative intravitreal ranibizumab and pars plana vitrectomy

Drug: Ranibizumab

Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

Other Names:

Lucentis

Placebo Comparator: PPV

Sham injection and pars plana vitrectomy

Other: Sham injection

Simulation of intravitreal injection one week before pars plana vitrectomy

Outcome Measures

Primary Outcome Measures

amount of intraoperative intra-ocular bleeding [one week]
amount of intra-ocular bleeding that occurred during pars plana vitrectomy

Secondary Outcome Measures

visual acuity [12 weeks]
ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

Massive vitreous hemorrhage preventing from detailed posterior pole examination;
Previous intra-ocular surgery other than cataract surgery
Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
Prothrombin time, partial thromboplastin time or platelet count without normal limits
History of previous thromboembolic events